FDA Enforcement Class II Terminated

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).

Recall: Z-0833-2015 · Reported December 31, 2014

Enforcement

Recall Number
Z-0833-2015
Event ID
64760
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Ge Healthcare It
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
December 31, 2014
Initiation Date
April 19, 2013
Classification Date
December 19, 2014
Termination Date
June 10, 2016
Address
540 W Northwest Hwy, Barrington, IL, 60010-3051, United States

Description

Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).

Reason

GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.

Code Info

Centricity Enterprise Archive versions: 4.0.x

Distribution

Nationwide Distribution including AZ, OH, WA.

Quantity

115 units